What changed in this filing

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Item 9A. Controls and Procedures

2025-03-12 compared with 2024-03-05 · 613 added, 475 removed, 661 unchanged (62% of the section changed)

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Other Information.

Trading Plans and Arrangements

the quarter ended December 31, 2024, none of our directors or officers notified us that they adopted , modified or terminated any Rule

10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement as defined in Item 408(a) of Regulation S-K.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

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officers and directors, on this website within four business days following the date of such amendment or waiver.

Trading Policy

have adopted a statement of trading policies that governs the trading in our securities by our directors, officers and certain other

covered persons, and which is reasonably designed to promote compliance with applicable insider trading laws, rules and regulations,

and any listing standards applicable to the Company.

A copy of the Insider Trading Policy is included as Exhibit 19.1 to this annual

In addition, with regard to any trading in our own securities, it is our policy to comply with the federal securities laws and

the applicable exchange listing requirements.

have adopted an Executive Officer Clawback Policy (the “Clawback Policy”), in accordance with the Nasdaq listing standards

and Exchange Act Rule 10D-1, which applies to our current and former executive officers.

Under the Clawback Policy, we are required to

recoup the amount of any Erroneously Awarded Compensation (as defined in the Clawback Policy) on a pre-tax basis within a specified lookback

period in the event of any Accounting Restatement (as defined in the Clawback Policy), subject to limited impracticability exception.

remaining information required by this Item 10 will be included in our definitive Proxy Statement for the 2025 Annual Meeting of Stockholders

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following financial statements are included herein:

Report of Kesselman & Kesselman, Independent Registered Public Accounting Firm

Report of Kesselman & Kesselman, Independent Registered Public Accounting Firm (PCAOB name:

Kesselman & Kesselman C.P.A.s and PCAOB

Consolidated Balance Sheets as of December 31, 2024 and 2023

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3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 5, 2013)

Form of Series B Warrant Agent Agreement and Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to Amendment No.3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 6, 2017)

Description of Securities

Description of Securities (incorporated by reference to Exhibit 4.1 to the Annual Report on Form 10-K filed on March 5, 2024)

Form of Indemnity Agreement between InspireMD, Inc.

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and Craig Shore (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 28, 2019)

Form of Underwriter Warrant, dated April 8, 2019 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on April 8, 2019)

Form of Series E Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, Amendment No.

1, filed with the SEC on September 13, 2019 (File No.

333-233432)).

Form of Underwriter Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, Amendment No.

1, filed with the SEC on September 13, 2019 (File No.

333-233432)).

Employment Agreement, dated December 9, 2019, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on December 10, 2019).

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Form of Restricted Stock Unit Award Agreement under the 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.62 to the Annual Report on Form 10-K filed on March 7, 2022)

Sales Agreement by and between InspireMD, Inc.

and A.G.P./Alliance Global Partners, dated June 3, 2022 (incorporated by reference to Exhibit 1.2 of the Registration Statement on Form S-3 as filed on June 3, 2022).

Third Amendment to Employment Agreement, dated January 5, 2023, by and between InspireMD, Inc.

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Fourth Amendment to Employment Agreement, dated August 14, 2020, by and between InspireMD, Inc.

and Craig Shore

and Craig Shore (incorporated by reference to Exhibit 10.62 to the Annual Report on Form 10-K filed on March 5, 2024)

Fourth Amendment to Employment Agreement, dated April 1, 2024, by and between InspireMD, Inc.

and Marvin Slosman (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K dated April 2, 2024)

Eighth Amendment to Employment Agreement, dated April 1, 2024, by and between InspireMD, Inc.

and Craig Shore (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K dated April 2, 2024)

Equity Distribution Agreement by and between InspireMD, Inc.

and Piper Sandler & Co., dated May 31, 2024 (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K dated May 31, 2024)

InspireMD, Inc.

2024 Inducement Plan (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K dated October 1, 2024)

Form of Inducement Restricted Stock Award Agreement (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K dated October 1, 2024)

Form of Inducement Nonqualified Stock Option Agreement (incorporated by reference to Exhibit 10.3 of the Current Report on Form 8-K dated October 1, 2024)

Form of Inducement Restricted Stock Unit Award Agreement (incorporated by reference to Exhibit 10.4 of the Current Report on Form 8-K dated October 1, 2024)

Lease Agreement, dated October 9, 2024, by and between InspireMD, Inc.

and ROIB Waterford, LLC (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K dated October 15, 2024)

Ninth Amendment to Employment Agreement, dated December 10, 2024, by and between InspireMD, Inc.

and Craig Shore (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K dated December 12, 2024)

Employment Agreement, dated Fe bruary 12, 2023, by and between InspireMD, Inc.

and Shane Gleason

Insider Trading Policy

List of Subsidiaries (incorporated by reference to Exhibit 21.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2011)

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InspireMD, Inc.

Executive Officer Clawback Policy

Executive Officer Clawback Policy (incorporated by reference to Exhibit 97.1 to the Annual Report on Form 10-K filed on March 5, 2024)

XBRL Instance Document (the Instance Document does not appear in the interactive data file because its XBRL tags are embedded within

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OF AND FOR THE YEAR ENDED DECEMBER 31, 2024

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name:

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name:

Kesselman & Kesselman C.P.A.s and PCAOB ID:

FINANCIAL STATEMENTS:

Consolidated Balance Sheets

Consolidated Statements of Operations

Consolidated Statements of Changes in Equity

Consolidated Statements of Cash Flows

Notes to the Consolidated Financial Statements

Balance Sheets

Statements of Operations

Statements of Changes in Equity

Statements of Cash Flows

to the Consolidated Financial Statements

of Independent Registered Public Accounting Firm

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and its subsidiaries (the “Company”) as of December

31, 2023 and 2022, and the related consolidated statements of operations, changes in equity and cash flows for the years then ended,

including the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated

financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022,

and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted

in the United States of America.

31, 2024 and 2023, and the related consolidated statements of operations, changes in equity and cash flows for each of the two years

ended December 31,2024, including the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company

as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years ended December 31, 2024

in conformity with accounting principles generally accepted in the United States of America.

Doubt About the Company’s Ability to Continue as a Going Concern

accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

in Note 1b to the consolidated financial statements, the Company has suffered recurring losses from operations and cash outflows from

operating activities that raise substantial doubt about its ability to continue as a going concern.

Management’s plans in regard

to these matters are also described in Note 1b.

The consolidated financial statements do not include any adjustments that might result

from the outcome of this uncertainty.

consolidated financial statements are the responsibility of the Company’s management.

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Those standards require

that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material

that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material

misstatement, whether due to error or fraud.

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statements and (ii) involved our especially challenging, subjective, or complex judgments.

We determined there are no critical audit

Kesselman & Kesselman

determined there are no critical audit matters.

/s/ Kessleman & Kesselman

Public Accountants (Isr.)

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BALANCE SHEETS

dollars in thousands)

dollars in thousands and except share and per share data)

CURRENT ASSETS:

Cash and cash equivalents

Short-term bank deposits

Cash and cash

Marketable securities

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Prepaid expenses

TOTAL CURRENT ASSETS

CURRENT ASSETS

NON-CURRENT ASSETS:

Property, plant and equipment, net

Operating lease right of use assets

Fund in respect of employee rights upon retirement

TOTAL NON-CURRENT ASSETS

Long term deposit

Property, plant and equipment,

Operating lease right of

in respect of employee rights upon retirement

NON-CURRENT ASSETS

LIABILITIES AND EQUITY

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Accounts payable and accruals:

TOTAL CURRENT LIABILITIES

CURRENT LIABILITIES

LONG-TERM LIABILITIES:

Operating lease liabilities

Liability for employee rights upon retirement

TOTAL LONG-TERM LIABILITIES

COMMITMENTS AND CONTINGENT LIABILITIES (Note 8)

TOTAL LIABILITIES

Common stock, par value $ 0.0001 per share;

net of current maturities

for employee rights upon retirement and others

LONG-TERM LIABILITIES

COMMITMENTS AND CONTINGENT

LIABILITIES (Note 8)

Common stock, par value

$ 0.0001 per share;

150,000,000 shares authorized at December 31, 2024 and 2023;

21,841,215 and 8,330,918 shares issued and outstanding at December 31, 2023 and 2022, respectively

Preferred C shares, par value $ 0.0001 per share;

26,611,033 and 21,841,215 shares issued and outstanding

at December 31, 2024 and 2023, respectively

Preferred C shares, par value $ 0.0001 per

1,172,000 shares authorized at December 31, 2024 and 2023;

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Additional paid-in capital

Accumulated deficit

Total liabilities and equity

liabilities and equity

* Represents an amount

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STATEMENTS OF OPERATIONS

dollars in thousands, except per share data)

Year Ended December 31,

dollars in thousands, except share and per share data)

Ended December 31,

COST OF REVENUES

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Selling and marketing

General and administrative

Total operating expenses

and administrative

operating expenses

LOSS FROM OPERATIONS

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LOSS BEFORE TAX EXPENSES

NET LOSS PER SHARE - basic and diluted

WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted

LOSS PER SHARE - basic and diluted

AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted

accompanying notes are an integral part of the consolidated financial statements.

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dollars in thousands, except share data)

Preferred Stock

Additional paid-in

BALANCE as of January 1, 2023

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 10,832 shares

Exercise of pre-funded

of common shares, pre-funded warrants and warrants, net of $ 4,635 issuance costs

compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 29,695 shares

BALANCE as of December

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dollars in thousands, except share data)

Preferred Stock

Additional paid-in

BALANCE as of January 1, 2024

Exercise of pre-funded warrants

Issuance of common shares, pre-funded warrants and warrants, net of $ 4,635 issuance costs

Share-based compensation related to stock, restricted stock,

restricted stock units and stock options award, net of forfeitures of 29,695

Share-based compensation related to stock, restricted stock,

restricted stock units and stock options award, net of forfeitures

Balance, value

Exercise of pre-funded

of Warrants Series H to 12,621,090 pre-funded warrants and 292,996 common stock, net of $ 1,000 issuance costs

of common stock, included at the market offering net of $ 81 issuance costs

compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 128,660 shares

BALANCE as of December

Balance, value

* Represents an amount

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dollars in thousands)

Year ended December 31,

CASH FLOWS FROM OPERATING ACTIVITIES:

Adjustments required to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

Gain from sale of property, plant and equipment

Change in fair value of markable securities, net of interest received

Change in liability for employees rights upon retirement

ended December 31,

CASH FLOWS FROM OPERATING

Adjustments required to

reconcile net loss to net cash used in operating activities:

Gain from sale of property,

plant and equipment

Change in fair value of

markable securities, net of interest received

Change in liability for

employees rights upon retirement

Other financial expense

Change in operating right of use asset and operating leasing liability

Share-based compensation expenses

Decrease (increase) in interest receivable on short term deposits

Loss (gain) on amounts funded in respect of employee rights upon retirement, net

Changes in operating asset and liability items:

Decrease in prepaid expenses

Decrease (increase) in trade receivables

Change in operating right

of use asset and operating leasing liability

Share-based compensation

Decrease in interest receivable

on short term deposits

Gain on amounts funded

in respect of employee rights upon retirement, net

Changes in operating asset

and liability items:

Decrease (increase) in

prepaid expenses

Decrease (increase) in

trade receivables

Increase in other receivables

Increase in inventory

Increase (decrease) in trade payables

Increase in other payables

Net cash used in operating activities

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchase of property, plant and equipment

Proceeds from sale of property, plant and equipment

Investment in short-term bank deposits

Investments in marketable securities

Proceeds from matured marketable securities

Amounts funded in respect of employee rights upon retirement

Withdrawal from short-term bank deposits

Net cash provided by (used in) investing activities

CASH FLOWS FROM FINANCING ACTIVITIES:

Issuance costs of At The Market offering

Proceeds from issuance of shares and warrants net of $ 4,635 issuance costs,

Net cash provided by (used in) financing activities

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR

SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:

Acquisition of right-of-use assets by means of lease liabilities

Increase in trade payables

in other payables

Net cash used in operating

CASH FLOWS FROM INVESTING

Purchase of property, plant

and equipment

Proceeds from sale of property,

plant and equipment

Investment in long-term

Investment in short-term

bank deposits

Investments in marketable

Proceeds from matured marketable

Amounts funded in respect

of employee rights upon retirement

from short-term bank deposits

cash provided by (used in) investing activities

CASH FLOWS FROM FINANCING

Proceeds from exercise

of warrants, net of $ 1,000 issuance costs

from issuance of shares and warrants, net of $ 81 and $ 4,635 issuance costs, respectively

cash provided by (used in) financing activities

OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

INCREASE IN CASH AND CASH

OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

OF CASH AND CASH EQUIVALENTS AT END OF YEAR

SUPPLEMENTAL NON-CASH INVESTING

AND FINANCING ACTIVITIES:

Acquisition of right-of-use assets by means

of lease liabilities

Non-cash lease incentive

Decrease in right-of-use assets and lease liabilities due to shortening lease term

Decrease in right-of-use assets and lease liabilities

due to shortening lease term

Non-cash purchase of property and equipment

accompanying notes are an integral part of the consolidated financial statements.

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1 - DESCRIPTION OF BUSINESS

Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on

the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular

and coronary disease.

MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.

Inc., a Delaware corporation (the “Company”), together with its subsidiaries, including InspireMD Ltd., an Israeli corporation,

and InspireMD GmbH, a German corporation, is a medical device company focusing on the development and commercialization of products

for the treatment of carotid artery disease and other vascular disease, including the Company’s proprietary CGuard™ stent

A stent is an expandable scaffold-like device, usually constructed of a metallic material, that is inserted into the lumen

of an artery to create patency and improved blood flow.

A sleeve of MicroNet™ mesh is attached over a stent to provide embolic

protection both during and after stenting procedures.

Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat

carotid artery disease.

Company ceased sales of the Company’s MGuard Prime EPS in the beginning of 2022.

Company market its products through distributors in international markets, mainly in Europe.

of the date of issuance of these consolidated financial statements, the Company has the ability to fund its planned operations for at

least the next 12 months.

However, the Company expects to continue incurring losses and negative cash flows from operations until its

product, CGuard™ EPS, reaches commercial profitability.

Therefore, in order to fund the Company’s operations until such time

that the Company can generate substantial revenues, the Company may need to raise additional funds.

of European Medical Device Regulation for marketing CGuard EPS in countries requiring the

the European Union (“EU”) nations, medical devices must obtain a CE mark before they may be placed on the market.

order to obtain and maintain the CE mark, the Company must comply with EU law on medical devices, which, until May 26, 2021 was governed

by the Medical Device Directive 93/42/EEC (“MDD”), by presenting comprehensive technical files for the Company’s

products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management

system audit as per ISO 13485 standard by a European Notified Body.

The Company has obtained ISO 13485 quality system certification

and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark.

In order to maintain

certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors.

The European Union

replaced the MDD with the new European Medical Device Regulation (MDR 2017/745) (“MDR”) regulations.

The MDR entered

into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic

on May 26, 2021 and which changes several aspects of the regulatory framework in the EU.

Manufacturers had the duration of the transition

period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark.

the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022.

14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health

Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023.

Subsequently, on March 20,

2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive

until December 31, 2027.

January 2024, the Company received CE mark recertification for the CGuard™ EPS under the EU’s Medical Device Regulation

regulatory framework and can market Cguard permanently in EU countries as long as the Company is able to maintain its regulatory

Related to Our Operations in Israel including the recent attack by Hamas and other terrorist

organizations from the Gaza Strip and Israel’s war against them.

October 2023, Israel was attacked by a terrorist organization and entered a state of war.

As of the date of these consolidated financial

statements, the war in Israel is ongoing and continues to evolve.

The Company operations including the production facility are located

Currently, such activities in Israel remain largely unaffected.

During the year ended December 31, 2023, the impact of this

war on the Company’s results of operations and financial condition was immaterial, but such impact may increase, which could be

material, as a result of the continuation, escalation or expansion of such war.

Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe

Company derived approximately 13.5 % and 12.1 % in the years ended December 31, 2023 and 2022,

respectively, of total sales in Russia and Belarus.

Company markets its products through distributors in international markets, mainly in Europe, and is seeking FDA approval for its

CGuard Prime carotid stent system to enter the U.S.

Company has an accumulated deficit as of December 31, 2024, as well as a history of net losses and negative operating cash flows.

The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches

commercial profitability.

As a result of these expected losses and negative cash flows from operations, along with the Company’s

current cash position, the Company does not have sufficient resources to fund operations for at least the next 12 months.

there is substantial doubt about the Company’s ability to continue as a going concern.

These consolidated financial statements

have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result

from the outcome of this uncertainty.

plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity

securities, debt or capital inflows from strategic partnerships and exercises of warrants.

There are no assurances however, that

the Company will be successful in obtaining the level of financing needed for its operations.

If the Company is unsuccessful in commercializing

its products and raising capital, it may need to reduce activities, curtail or cease operations.

Related to the Company’s Operations in Israel

October 2023, Israel was attacked by a terrorist organization and entered a state of war on several fronts.

As of the date of these

consolidated financial statements, sustained conflict in the region is ongoing and Israel has entered into certain ceasefires, the

results of which are uncertain.

The Company operations, including its production facility, are located in Israel.

Currently, such

activities in Israel remain largely unaffected.

the years ended December 31, 2024 and 2023, the impact of this war on the Company’s results of operations and financial condition

was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion of

Risks Related to the Geopolitical and Military Tensions

Between Russia and Ukraine in Europe

The Company derived approximately 14.5 % and 13.5 %

in the years ended December 31, 2024 and 2023, respectively, of total sales in Russia and Belarus.

The escalation of geopolitical instability

in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively

impact the Company’s operations, sales, and future growth prospects in that region.

a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and

entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region.

The Company cannot provide assurance that potential future changes in sanctions will not have a material impact on the Company’s

operations in Russia and Belarus or on the Company’s financial results.

in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales,

and future growth prospects in that region.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

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Use of estimates

preparation of financial statements in conformity with U.S.

GAAP requires management to make estimates using assumptions that affect

the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and

the reported amounts of revenues and expenses during the reporting periods.

The preparation of financial statements in conformity with U.S.

GAAP requires management to make estimates using assumptions that

affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements

and the reported amounts of revenues and expenses during the reporting periods.

Actual results could differ from those estimates.

applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations

and assessing the likelihood of exercise of options to extend the lease term.

As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to the determination

of the lease terms in operating leases.

Functional currency

The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the

The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the U.S.

dollar (“$” or “dollar”).

Accordingly, the functional currency of the Company and its subsidiaries is the

Accordingly, the functional currency of the Company and its subsidiaries is the U.S.

The dollar figures are determined as follows:

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Cash and cash equivalents

The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase

date to be cash equivalents.

As of December 31, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months

from the date of deposit) and money market funds.

As of December 31, 2022, this balance consisted solely of cash.

Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to

be cash equivalents.

As of December 31, 2024 and 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three

months from the date of deposit) and money market funds.

Marketable securities

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on a fair value basis.

Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements

of operation as finance expense (income), net.

securities are classified under current assets in the consolidated balance sheet as they represent the investment of funds available

Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the consolidated

statements of operation as finance expense (income), net.

securities are classified under current assets in the consolidated balance sheets as they represent the investment of funds available

for the Company’s current operations.

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2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

Short-term bank deposits

Bank deposits with original maturities of more than three months but less than one year are presented as part of short-term bank

Deposits are presented at their cost which approximates market values including accrued interest.

Interest on deposits is recorded

as financial income.

Concentration of credit risk and allowance for doubtful accounts

Financial instruments that may potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents,

and short-term bank deposits, which are deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts

receivable and other receivables.

The Company’s trade accounts receivable is derived from revenues earned from customers from various

The Company performs ongoing credit evaluations of its customers’ financial condition and, requires no collateral from

its customers.

marketable securities and long-term deposits, which are deposited in major financially sound institutions in the U.S.

Israel and Germany,

and trade accounts receivable and other receivables.

The Company’s trade accounts receivable is derived from revenues earned from

customers from various countries.

The Company performs ongoing credit evaluations of its customers’ financial condition and, requires

no collateral from its customers.

The Company also has a credit insurance policy for some of its customers.

The Company maintains the allowance for estimated

losses resulting from the inability of the Company’s customers to make required payments.

The allowance represents the current

estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions

and supportable forecasts when appropriate.

The estimate is a result of the Company’s ongoing evaluation of collectability, customer

creditworthiness, historical levels of credit losses, and future expectations.

The allowance for expected credit losses was immaterial

during the periods presented.

The Company maintains the

allowance for estimated losses resulting from the inability of the Company’s customers to make required payments.

The allowance

represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering

current market conditions and supportable forecasts when appropriate.

The estimate is a result of the Company’s ongoing evaluation

of collectability, customer creditworthiness, historical levels of credit losses, and future expectations.

The allowance for expected

credit losses was immaterial during the periods presented.

Inventories are stated at the lower of cost (cost is determined on a “first-in, first-out” basis) or net realizable

2 unchanged sentences

impairment has occurred, the Company impairs the inventories’ carrying value.

There were no impairments or inventory allowances

during the years ended December 31, 2024 and 2023.

Operating leases are included in operating lease right-of-use (“ROU”) assets.

Short-term balances regarding lease liabilities are included in accounts payable and accruals - Other and long-term balances regarding lease liabilities are included in operating lease liabilities.

ROU assets represent Company’s right to use an underlying asset for the lease term and lease liabilities represent obligation to make lease payments arising from the lease.

Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term.

In determining the present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease is not readily determinable.

The determination of the incremental borrowing rate requires management judgment based on information available at lease commencement.

The lease terms may include periods covered by options to extend the lease when it is reasonably certain that the Company will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that the Company will not exercise such options.

Short-term balances regarding lease liabilities

are included in accounts payable and accruals - Other and long-term balances regarding lease liabilities are included in operating lease

ROU assets represent Company’s right to use an underlying asset for the lease term and lease liabilities represent

obligation to make lease payments arising from the lease.

Operating lease ROU assets and liabilities are recognized at the lease commencement

date based on the present value of lease payments over the lease term.

In determining the present value of lease payments, the Company

uses the incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease

is not readily determinable.

The determination of the incremental borrowing rate requires management judgment based on information available

at lease commencement.

The lease terms may include periods covered by options to extend the lease when it is reasonably certain that

the Company will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that the

Company will not exercise such options.

Operating lease cost is recognized on a straight-line basis over the lease term.

Lease agreements that include lease and non-lease components are accounted for as a single lease component.

The Company elected the short-term lease recognition exemption for leases with a lease term of 12 months or less.

Lease agreements

that include lease and non-lease components are accounted for as a single lease component.

The Company elected the short-term lease recognition

exemption for leases with a lease term of 12 months or less.

Property, plant and equipment

22 unchanged sentences

Revenue from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once

the Company has a present right to payment and the customer has legal title, and risk and rewards of ownership are obtained by the customer.

the Company has a present right to payment and the customer has legal title, and risks and rewards of ownership are obtained by the customer.

Generally, this occurs when products are shipped.

8 unchanged sentences

Research and development costs

Research and development costs, including the costs of the Company’s US based clinical trial costs were approximately $ 3,300,000

and $ 4,468,000

for the years ended December 31, 2023 and 2022,

respectively, and charged to the statement of operations as incurred.

Research and development costs, including the costs of the Company’s U.S.-based clinical trial costs which were approximately

thousand for the years ended December 31, 2024

and 2023, respectively, are charged to the consolidated statements of operations as incurred.

Share-based compensation

8 unchanged sentences

The Company elected to account for forfeitures as they

Company elected to recognize compensation expenses for awards to employees with only service conditions that have graded vesting schedules

using the accelerated multiple option approach.

The attribution for nonemployee awards is in the same manner as if the Company

had paid cash for the goods or services.

In addition, certain of our share-based awards to service providers are performance based, i.e.,

the vesting of these awards depends upon achieving certain goals.

The company recognizes compensation expenses for awards with performance

conditions when the company concludes that it is probable that the performance condition will be achieved.

The Company elected to recognize compensation expenses for awards to employees with only service conditions that have graded vesting

schedules using the accelerated multiple option approach.

The attribution for nonemployee awards is in the same manner as if the

Company had paid cash for the goods or services.

addition, some of our share-based awards to service providers are performance based, i.e., the vesting of these awards depends upon achieving

certain goals.

The Company recognizes compensation expenses for awards with performance conditions when the company concludes that it

is probable that the performance condition will be achieved.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

Uncertain tax positions

4 unchanged sentences

If under the first step a tax position is assessed to be more likely than not of being sustained on audit,

the second step is performed, under which the

tax benefit is measured as the largest amount that is more than 50% likely to be realized upon ultimate settlement.

liabilities are classified as long-term, unless the liability is expected to be resolved within twelve months from the balance sheet

The Company’s policy is to include interest related to unrecognized tax benefits within “Financial expenses - net”.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

the second step is performed, under which the tax benefit is measured as the largest amount that is more than 50% likely to be realized

upon ultimate settlement.

Such liabilities are classified as long-term, unless the liability is expected to be resolved within twelve

months from the balance sheet date.

The Company’s policy is to include interest related to unrecognized tax benefits within “Financial

income - net”.

Deferred income taxes

Deferred taxes are determined utilizing the “asset and liability” method based on the estimated future tax effects

6 unchanged sentences

The Company may incur an additional tax liability in the event of intercompany dividend distributions by its subsidiaries.

additional tax liability in respect of these foreign subsidiaries has not been provided for in these financial statements as it is the

Company’s policy to permanently reinvest the subsidiaries’ earnings and to consider distributing dividends only in connection

with a specific tax opportunity that may arise.

additional tax liability in respect of these foreign subsidiaries has not been provided for in these consolidated financial statements

as it is the Company’s policy to permanently reinvest the subsidiaries’ earnings and to consider distributing dividends only

in connection with a specific tax opportunity that may arise.

Taxes that would apply in the event of disposal of investments in a foreign subsidiary have not been taken into account in computing

the deferred taxes, as it is the Company’s intention to hold, and not to realize, these investments.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

Costs related to advertising and promotion of products are charged to sales and marketing expense as incurred.

1 unchanged sentence

were approximately $ 691 and

$ 359,000 for

$ 426 thousand for

the years ended December 31, 2024 and 2023, respectively.

5 unchanged sentences

units and Series C preferred stock as the effect is anti-dilutive.

For the purpose of calculating basic net loss per share, the

additional shares of common stock that are issuable upon exercise of the Pre-funded Warrants have been included since the shares are

issuable for a negligible consideration, as determined by the Company according to ASC 260-10-45-13, and have no vesting or other contingencies

associated with them.

For the year ended December 31, 2023, we had weighted average Pre-funded Warrants to purchase 9,612,502

share of common stock, which was used in the

computation of net loss per share for the year.

The total number of shares of common stock related to outstanding options, warrants,

unvested restricted stock, unvested restricted stock units and Series C Preferred Stock, which were excluded from the calculations of

diluted loss per share were 74,978,006

For the purpose of calculating basic net loss per share, the additional shares of common stock that are

issuable upon exercise of the Pre-funded Warrants have been included since the shares are issuable for a negligible consideration, as

determined by the Company according to ASC 260-10-45-13, and have no vesting or other contingencies associated with them.

total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted stock

units and Series C Preferred Stock, which were excluded from the calculations of diluted loss per share were 48,681,495

and 59,723,455

1 unchanged sentence

respectively .

This amount includes 3,054,086

of unvested restricted stock included in the

number of issued and outstanding shares as of December 31, 2023 and 2022, respectively.

This amount includes 4,073,966 and 3,054,086 of unvested restricted

stock included in the number of issued and outstanding shares as of December 31, 2024 and 2023, respectively.

the years ended December 31, 2024 and 2023 the weighted average number of ordinary shares used in computing net loss per share -

basic and diluted was as

SCHEDULE OF WEIGHTED AVERAGE NUMBER OF SHARES

Weighted average number of ordinary shares

Weighted average Vested restricted stock units

Weighted average Pre-funded Warrants

Total Weighted average number of

ordinary shares used in computing net loss per share - basic and diluted

Segment reporting

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operating and reportable segment.

The Company has adopted the

new accounting standard ASU 2023-07 “Segment Reporting:

Improvements to Reportable Segment Disclosures” in 2024, see note

Fair value measurement

6 unchanged sentences

Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities.

fair value hierarchy gives the highest priority to Level 1 inputs.

value hierarchy gives the highest priority to Level 1 inputs.

Observable prices that are based on inputs not quoted on active markets but corroborated by market data.

2 unchanged sentences

to Level 3 inputs.

determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of

unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the

use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

2 - SIGNIFICANT ACCOUNTING POLICIES (continued):

Recently adopted accounting pronouncement

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments.

This guidance replaces the incurred loss impairment methodology.

Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts.

In November 2019, the FASB issued ASU No.

2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842):

Effective Dates (“ASU 2019-10”).

The purpose of this amendment is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities.

This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13.

Larger public companies had an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years.

All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022.

Under the current SEC definitions, the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13.

The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption.

The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.

Recently issued accounting pronouncement, not yet adopted

November 2023, the FASB issued ASU 2023-07 “Segment Reporting:

Improvements to Reportable Segment Disclosures”.

This guidance

expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly

provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description

of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets.

entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280.

The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after

December 15, 2024, with early adoption permitted.

The amendments are required to be applied retrospectively to all prior periods presented

in an entity’s financial statements.

The Company is currently evaluating this guidance to determine the impact it may have on its

consolidated financial statements related disclosures.

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic

Improvements to Income Tax Disclosures”.

guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures.

The amendments in ASU 2023-09

address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation

and income taxes paid both in the U.S.

This guidance is intended to enhance the transparency and decision-usefulness of

income tax disclosures.

The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through

changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S.

and in foreign jurisdictions.

ASU 2023-09 is effective for fiscal years beginning after

December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively.

is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively.

Early adoption is permitted.

Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements

August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting

for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on

an entity’s own equity.

This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods

within those fiscal years.

The initial adoption of ASU 2020-06 is not expected to have a material impact on the Company’s consolidated

financial statements.

The Company is currently evaluating this guidance to determine the impact it may have on its consolidated

financial statements and disclosures.

In November 2024, the FASB issued ASU No.

2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40).

The ASU improves

the disclosures about a public business entity’s expenses and provides more detailed information about the types of expenses in

commonly presented expense captions.

The amendments require that at each interim and annual reporting period an entity will, inter alia,

disclose amounts of purchases of inventory, employee compensation, depreciation and amortization included in each relevant expense caption

(such as cost of sales, SG&A and research and development).

The ASU is effective for fiscal years beginning after December 15, 2026,

and interim periods within fiscal years beginning after December 15, 2027.

Early adoption is permitted.

The Company is currently evaluating

this ASU to determine its impact on the Company’s financial statements and disclosures.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

3 – FAIR VALUE MEASUREMENTS

of December 31, 2023, the carrying amounts of accounts payable, accounts receivable and other receivable approximate their fair values

due to the short-term maturities of these instruments.

of December 31, 2024 and 2023, the carrying amounts of accounts payable, accounts receivable and other receivables

approximate their fair values due to the short-term maturities of these instruments.

The carrying amount of the long-term deposit approximates its fair value since it is measured at its present

value applying prevailing interest rates, see note 7.

Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements

1 unchanged sentence

OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS

As of December 31, 2023

of December 31, 2024

in thousands)

Cash equivalents-

Money market funds

Marketable securities-

U.S government bonds

Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and

models utilizing market observable inputs to determine their fair value.

cost of Marketable securities as of December 31, 2023 is $ 28,727,000 .

government bonds

of December 31, 2023

in thousands)

government bonds

Company’s debt securities are classified within Level 1 and Level 2 because it uses quoted market prices or alternative pricing

sources and models utilizing market observable inputs to determine their fair value.

cost of marketable securities as of December 31, 2024 and 2023 is $ 15,277 and 28,727 thousand, respectively.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

4 - MARKETABLE SECURITIES

1 unchanged sentence

OF MARKETABLE SECURITIES

December 31, 2023

in thousands)

U.S government bonds

government bonds

Marketable securities

1 unchanged sentence

OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY

December 31, 2023

in thousands)

Amounts maturing within one year

Amounts maturing after one year through two years

table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the year ended December

Amounts maturing after

one year through two years

Marketable securities

table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the years ended December

31, 2024 and 2023:

OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES

in thousands)

Balance at beginning of the period

Sale or maturity

Balance at beginning of the year

Interest received

Changes in fair value

Balance at end of the period

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

during the year

Balance at end of the

5 - PROPERTY, PLANT AND EQUIPMENT

Composition of

assets, grouped by major classifications, is as follows:

of assets, grouped by major classifications, is as follows:

OF PROPERTY PLANT AND EQUIPMENT

4 unchanged sentences

Leasehold improvements

plant and equipment, gross

Less - accumulated depreciation and amortization

Property plant and equipment, gross

Less - accumulated depreciation

and amortization

Net carrying amount

and amortization expenses totaled approximately $ 280,000 and $ 232,000 for the years ended December 31, 2024, and 2023, respectively,

6 - LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT

excluding fixed assets that the company purchased, which is awaiting FDA approval and, as a result, is not yet operational and not

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

6 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT AND OTHERS

labor law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other

6 unchanged sentences

and $ 256,000 for the years ended December 31, 2024 and 2023, respectively.

severance pay liability of the Company for the rest of its Israeli employees, which reflects the undiscounted amount of the liability,

is based upon the number of years of service and the latest monthly salary.

The severance pay liability is partly covered by insurance

policies and by regular deposits with recognized severance payment funds.

The Company may only withdraw funds previously deposited for

savings in connection with the payment of severance.

The severance pay expenses for such employees were approximately $ 116,000 and $ 68,000

for the years ended December 31, 2023 and 2022, respectively.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

The severance pay liability of the

Company for the rest of its Israeli employees amounting to $ 1,224

thousand and $ 1,084

thousand for the years ended December 31, 2024 and 2023, respectively, reflects the undiscounted amount of the liability and is

based upon the number of years of service and the latest monthly salary.

severance pay liability is partly covered by insurance policies and by regular deposits with recognized severance payment funds.

Company may only withdraw funds previously deposited for savings in connection with the payment of severance.

The severance pay expenses

for such employees were approximately $ 124,000

and $ 116,000

for the years ended December 31, 2024 and 2023,

respectively.

7 – LEASE AGREEMENTS

Company’s Israeli subsidiary had a lease agreement for a facility in Israel, which expired on December 31, 2022 with an option

to extend the agreement for two additional years until December 31, 2024.

On May 25, 2022 the Company amended the agreement mentioned

above and extended it until December 31, 2026 as well as leasing of additional space in the facility.

On August 24, 2023, the Company amended the lease agreement mentioned above, leasing additional space in the facility and shortened the lease term of another space in the building.

The balances of right of use assets and lease liabilities increased due to the newly leased space and decreased due to the lease that was shortened.

lease cost for the years ended December 31, 2023 and 2022 was $ 433,000

and $ 442,000 respectively.

October 9, 2024, the Company entered into a lease agreement in Miami, Florida (the “U.S.

Lease”) for the establishment of its new global headquarters.

commences on the date that the landlord delivers the entire premises to the Company with (i) the landlord’s completion of the

construction of Suite 280 and (ii) the construction of Suite 215 being substantially complete (the “Commencement Date”).

lease will be in effect until August 31, 2030, with an option for a five-year extension in accordance with the lease terms.

However, the Company has determined that the lease renewal option is not reasonably certain to be exercised due to operational and

strategic factors.

Lease, the Company will pay the landlord a security deposit of $ 500

Provided the Company does not default, the security deposit will be refunded at specified intervals throughout the lease

The present value of the deposit as of December 31, 2024, is $ 426

thousand, and it is classified as Long-term Deposit while the remaining is included as Operating Lease Right of Use Assets.

Company took possession of Suite 215 as of November 1, 2024 (“Commencement Date”), and it expects to take possession of Suite 280 in May 2025 following

the substantial completion of landlord improvements as outlined in the U.S.

2) The Company’s Israeli subsidiary had a lease agreement for a facility

in Israel (the “Israeli Lease”), which expired on December 31, 2022 with an option to extend the Israeli Lease for two additional

years until December 31, 2024.

On May 25, 2022 the Company amended the Israeli Lease and extended it until December 31, 2026 and also

leased additional space in the facility.

On August 24, 2023, the Company amended the Israeli Lease, leasing additional space in the facility and

shortened the lease term of another space in the building.

The balances of right of use assets and lease liabilities increased due to

the newly leased space and decreased due to the lease that was shortened.

On March 14, 2024, the Company amended the

Israeli Lease, modifying the structure of the extension options.

While the lease term currently extends through December 31, 2027, any

extensions beyond this date are subject to the landlord’s approval and are not solely at the Company’s discretion.

In the fourth quarter of 2024, as part of

the approval of the Company’s long term strategic production plan, the Company reassessed its long-term leasing strategy.

this reassessment, the Company updated its assumption on the lease term for the Israeli premise and included the optional period until

the end of 2027 within the lease term.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

lease cost for the years ended December 31, 2024 and 2023 in Tel-Aviv was $ 423 and $ 433 thousand respectively.

lease cost for the years ended December 31, 2024 and 2023 in Miami was $ 34

thousand and $ 0 respectively.

In addition to the fixed lease payments in Miami, the Company

incurred variable expenses related to the lease, including utilities, maintenance, and other common area costs, totaling approximately

$ 21 thousand for the year ended December 31, 2024.

information related to leases are as follows:

SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES

in thousands)

Operating lease right-of-use assets

Current Operating lease liabilities

Non-current operating lease liabilities

Operating cash flows from operating leases (cash paid in thousands)

lease right-of-use assets

Current Operating lease

Non-current operating

lease liabilities

cash flows from operating leases (cash paid in thousands)

Weighted Average Remaining Lease Term

Weighted Average Discount Rate

of lease liabilities are as follows:

of lease liabilities as of December 31, 2024 are as follows:

SCHEDULE OF MATURITIES OF LEASE LIABILITIES

17 unchanged sentences

conducting the clinical trials, which reimbursement will not exceed USD 1,000,000 .

The financial statements include a liability, based

on 50 % of the Distributor costs incurred until December 31, 2023.

The liability at December 31, 2023 is immaterial.

Company’s common stock are listed on the Nasdaq Capital Market.

May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the

Company agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares

(the “Private Placement Shares”) of the Company’s common stock, pre-funded warrants (the “Pre-Funded Warrants”)

to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock,

consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series

I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase

up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,078

shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series

J Warrants, the “Warrants”), at an offering price of $ 1.6327 per Private Placement Share and associated Warrants and

an offering price of $ 1.6326 per Pre-Funded Warrant and associated Warrants.

The consolidated financial statements include a liability,

based on 50 % of the Distributor costs incurred until December 31, 2024.

The liability at December 31, 2023 and 2024 is immaterial.

Company’s shares of common stock are listed on the Nasdaq Capital Market.

May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company

agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private

Placement Shares”) of the Company’s common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase

up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting

of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to

purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086

shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,078 shares of common stock

(the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”),

at an offering price of $ 1.6327 per Private Placement Share and associated Warrants and an offering price of $ 1.6326 per Pre-Funded Warrant

and associated Warrants.

The Private Placement Offering closed on May 16, 2023.

gross proceeds to the Company in respect of the Private Placement Offering were $ 42.2 million, before deducting fees payable to the

placement agent and other offering expenses payable by the Company which amounted to approximately $ 4.6 million.

If the Warrants

are exercised in cash in full this would result in an additional $ 71.4 million of gross proceeds.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

NOTE 9 – EQUITY (continued):

Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001 per share and will not expire until exercised in

gross proceeds to the Company in respect of the Private Placement Offering were $ 42.2 million, before deducting fees payable to the placement

agent and other offering expenses payable by the Company which amounted to approximately $ 4.6 million.

If the Warrants are exercised

in cash in full this would result in an additional $ 71.4 million of gross proceeds.

Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001 per share and will not expire until exercised in full.

The Warrants are immediately exercisable upon issuance at an exercise price of $ 1.3827 per share.

The Warrants have a term

of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following

the Company’s public release of primary and secondary end points related to one year follow up study results from the Company’s

C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of

receipt of Premarket Approval (PMA) from the Food and Drug Administration, or FDA, for the CGuard Prime Carotid Stent System (135

cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval

for the SwitchGuard transcarotid system and CGuard Prime 80 cm and (D) in the case on the Series K Warrants, 20 trading days following

the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System

in the United States begin.

The Warrants may be exercised on a cashless basis if there is no effective registration statement registering

the shares underlying the warrants.

Company issued a total of 307,260 shares of its common stock in connection with the exercise of Pre-Funded Warrants to purchase 307,271

shares of common stock on a cashless basis.

As of December 31, 2023, there are Pre-Funded Warrants to purchase an aggregate

of 15,254,623 share of common stock outstanding.

to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series

C Preferred Stock, the conversion price of the outstanding shares of the Series C Preferred Stock was reduced to $ 1.3827 per share,

effective as of the date of the securities purchase agreement entered for the Offering, and the number of shares of common stock

issuable upon conversion of the Series C Preferred Stock increased by 5,668 additional shares of common stock upon conversion of

the Series C Preferred Stock, based on 1,718 shares of Series C Preferred Stock outstanding as of May 16, 2023.

The Warrants have a term of the earlier

of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following the Company’s

public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal

trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval

(PMA) from the Food and Drug Administration, or FDA, for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series

J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard transcarotid system

and CGuard Prime 80 cm and (D) in the case on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after

the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in the United States begin.

The Warrants may

be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.

2024 and 2023, the Company issued a total of 1,728,382 and 307,260 shares

of its common stock, respectively, in connection with the exercise of Pre-Funded Warrants to purchase 1,728,390 and

307,271 , respectively, shares of common stock of which 200,000 and 307,271 , respectively, Pre-Funded Warrants were exercised to

199,992 and 307,260 shares of its common stock on a cashless basis.As of December 31, 2024 and 2023, there are Pre-Funded Warrants

to purchase an aggregate of 26,147,323 and 15,254,623 ,

respectively shares of common stock outstanding.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

OF EXERCISE OF WARRANTS AND PRE FUNDED WARRANTS

to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series C

Preferred Stock, the conversion price of the outstanding shares of the Series C Preferred Stock was reduced to $ 1.3827 per share, effective

as of the date of the securities purchase agreement entered for the Offering, and the number of shares of common stock issuable upon

conversion of the Series C Preferred Stock increased by 5,668 additional shares of common stock upon conversion of the Series C Preferred

Stock, based on 1,718 shares of Series C Preferred Stock outstanding as of May 16, 2023.

of December 31, 2024 and 2023, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 7,952

7,952 and 2,284 shares of the Company’s common stock, respectively with a total stated value of $ 10,997 .

shares of the Company’s common stock, with a total stated value of $ 10,997 .

of Series H Warrant

Series H Warrants had a term of the earlier of (i) five years from the date of issuance and (ii) (A) 20 trading days following the Company’s

public release of primary and secondary end points related to one year follow up study results from the Company’s C-GUARDIANS pivotal

the announcement on May 28, 2024 of the one year follow up study results from the Company’s C-GUARDIANS pivotal trial, the Series

H Warrants were exercised in full into 292,996 shares of common stock and pre-funded warrants exercisable into 12,621,090 shares of common

The net proceeds to the Company from the exercise of the Series H Warrants were $ 16.9 million after deduction of placement agent

fees of approximately $ 1 million.

The Series H Warrants, each exercisable at $ 1.3827 per share of common stock and $ 1.3826 per pre-funded

warrant, were issued as part of the Private Placement Offering.

May 31, 2024, the Company entered into an at-the-market (“ATM”) facility with Piper Sandler & Co.

pursuant to an Equity Distribution Agreement (the “Distribution Agreement”).

In accordance with the Distribution Agreement,

the Company is entitled, at its sole discretion, to offer and sell through or to Piper Sandler, acting as a sales agent, shares of its

common stock having an aggregate offering price of up to $ 17.0 million throughout the period during which the ATM facility remains in

The Company has agreed to pay Piper a commission of 3.0 % of the gross proceeds from the sale of shares of common stock under

the ATM facility.

For the year ended December 31, 2024, the net proceeds to the Company from the issuance of 647,277 shares of common

stock were $ 1,598 thousand after deduction of issuance fees of approximately $ 81 thousand.

of December 31, 2024, the Company has outstanding warrants to purchase an aggregate of 40,268,464 shares of common stock as follows:

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

Number of underlying

Series E Warrants

Series F Warrants

June 5, 2025-October 16, 2025

Series G Warrants

Series H Warrants

February 8, 2026

Series I Warrants

1 unchanged sentence

Series K Warrants

Underwriter Warrants

Total Warrants

of December 31, 2023, the Company has 155,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 150,000,000

are shares of common stock and 5,000,000 are shares of “blank check” preferred stock.

Warrants have a term of the earlier of (i) May 15, 2028 and (ii) (A) in the case of the Series

I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket

Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid

Stent System (135 cm), (B) in the case of the Series J Warrants, 20 trading days following

the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard

Prime 80 and (C) in the case on the Series K Warrants, 20 trading days following the end

of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales

of the CGuard Carotid Stent System in the United States begins.

the years ended December 31, 2024 and 2023, a total of 213,458 and 54,135 warrants expired, respectively.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

9 – EQUITY (continued):

September 30, 2021, at our 2021 annual meeting of stockholders, our stockholders approved

our 2021 Equity Incentive Plan.

2021 Equity Incentive Plan provides for the granting of incentive stock options, nonqualified stock options, stock

September 30, 2021, at the Company’s 2021 annual meeting of stockholders, the Company’s

stockholders approved the 2021 Equity Incentive Plan.

Company’s 2021 Equity Incentive Plan provides for the granting of incentive stock options, nonqualified stock options, stock

appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalent rights, and other awards,

which may be granted singly, in combination, or in tandem.

of December 31, 2023, we had 7,731,618 shares of common stock available for future issuance under our 2021 Equity Incentive Plan.

of December 31, 2024, we had 9,237,869 shares of common stock available for future issuance under the 2021 Equity Incentive Plan.

On September 30, 2024, the compensation committee of the Company’s board of directors approved the InspireMD, Inc.

2024 Inducement

Plan (the “2024 Inducement Plan”) to be used exclusively for grants of equity-based awards to individuals who were not previously

employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company.

of December 31, 2024, the Company had 1,957,763 shares of common stock available for future issuance under the 2024 Inducement Plan.

following table summarizes information about stock options granted to employees:

SCHEDULE OF STOCK OPTIONS GRANTED

Year ended December 31

Number of options

exercise price

Number of options

Weighted average exercise price

Outstanding - beginning of period

ended December 31

average exercise

Outstanding - beginning of the

Outstanding- end of period

Exercisable at the end of the period

Exercisable at the end

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

following table summarizes information about stock options granted to non-employees:

Year ended December 31

Number of options

Weighted average exercise price

Number of options

Weighted average exercise price

Outstanding - beginning of period

ended December 31

average exercise

Outstanding - beginning of the year

Outstanding - end of period

Exercisable at the end of the period

Exercisable at the end

following table summarizes information about restricted stock granted to employees:

SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES

Year ended December 31

Number of restricted stock

Outstanding - beginning of period

Outstanding - end of period

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

9 – EQUITY (continued):

ended December 31

of restricted stock

Outstanding - beginning of the year

( 1,069,428 )

Outstanding - end of the year

following table summarizes information about RSUs granted to employees:

SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES

Year ended December 31

Number of RSUs

Outstanding - beginning of period

Outstanding - end of period

ended December 31

Outstanding - beginning of the year

Outstanding - end of the year

following table provides additional information about all options outstanding and exercisable:

SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE

Outstanding as of December 31, 2023

Options outstanding

Weighted average remaining contractual life (years)

Options exercisable

as of December 31, 2024

average remaining contractual life (years)

$ 1.15 - 3.14

8 unchanged sentences

weighted average fair value of restricted stock granted was $ 2.94 and $ 1.95 for the years ended December 31, 2024 and 2023, respectively.

weighted average fair value of RSU granted was $ 1.76 for the year ended December 31, 2023.

weighted average fair value of RSU granted was $ 3.14 and $ 1.76 for the years ended December 31, 2024 and 2023, respectively.

vesting period for outstanding stock options, restricted stock, and RSUs is typically three years , with one-third of the awards vesting

Additionally, some of our share-based awards to service providers are performance-based, vesting upon the achievement of specified

performance criteria related to clinical or marketing activities.

The options and restricted stock to directors are subject to a one-year vesting period.

Additionally, some of our share-based

awards to service providers are performance-based, vesting upon the achievement of specified performance criteria related to clinical

or marketing activities.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

9 – EQUITY (continued):

following table sets forth the assumptions that were used in determining the fair value of options granted to employees for the year

December 31, 2023 and 2022:

following table sets forth the assumptions that were used in determining the fair value of options granted to employees and consultants

for the year December 31, 2024 and 2023:

SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES

Year ended December 31

ended December 31

Expected life

5.125 - 6.5 years

Risk-free interest rates

18 unchanged sentences

SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE

Year ended December 31

ended December 31

in thousands)

5 unchanged sentences

10 – RELATED PARTIES TRANSACTIONS

the twelve months ended December 31, 2023 and 2022, a consulting company whose founder and CEO is our board member provided certain

marketing services in the amount of $ 788 and $ 9,645 , respectively.

September 15, 2023, the board approved the company’s entry into a consultancy agreement with a member of the immediate family

of the CEO for certain administrative projects in connection with the Company’s expansion to the U.S.

until a full-time Company

employee is retained in such capacity.

Pursuant to the Consultancy Agreement, the Company will pay a fixed hourly fee of $ 50 for

a maximum of 20 hours per week and customary expenses.

The Company may terminate this Agreement for any reason or no reason, at any

time, upon 30 days prior written notice to consultant.

expenses for the year ended December 31, 2023, were $ 11,440 .

Receive Shares of Common Stock in lieu of Cash Compensation

the year 2023, certain non-employee directors elected to receive all or a portion of their cash retainer amount in shares of the Company’s

the year ended December 31, 2023, a consulting company whose founder and chief executive

officer is one of our board members provided certain marketing services in the amount of

No services were provided during the year ended December 31, 2024.

September 15, 2023, the board approved the company’s entry into a consultancy agreement

(the “Consultancy Agreement”) with a member of the immediate family of the Company’s

chief executive officer for certain administrative projects in connection with the Company’s

expansion to the U.S.

until a full-time Company employee is retained in such capacity.

to the Consultancy Agreement, the Company will pay a fixed hourly fee of $ 50 for a maximum

of 20 hours per week and customary expenses.

On July 1, 2024 the audit committee amended

the Consultancy Agreement.

Pursuant to the amended Consultancy Agreement, the Company will

pay a fixed hourly fee of $ 100 for a maximum of 95 hours per month in an aggregate amount

not to exceed $ 120,000 , including expenses, for the subsequent twelve month period until

June 30, 2025.

expenses for the years ended December 31, 2024 and 2023, were $ 75,522 and $ 11,440 , respectively.

to Receive Shares of Common Stock in lieu of Cash Compensation

2023, certain non-employee directors elected to receive all or a portion of their cash retainer amount in shares of the Company’s

common stock under the 2021 Equity Incentive Plan.

4 unchanged sentences

the Issuance Dates.

the years ended December 31, 2023 the Company issued 52,129 shares of common stock to non-employee directors who elected to receive all

For the year ended 2024, no expenses were recorded in shares of the company.

the year ended December 31, 2023 the Company issued 52,129 shares of common stock to non-employee directors who elected to receive all

or a portion of their cash retainer amount for the nine months ended September 30, 2023 in shares of the Company’s common stock

under the 2021 Equity Incentive Plan.

of December 31, 2023, there was an accrual for $ 55,000 for director’s fees for the three months ended December 31, 2023.

Out of this an amount of $ 22,875 was paid in cash and $ 32,125 was issued in shares of the Company’s common stock under the 2021

Equity Incentive Plan.

of December 31, 2023, there was an accrual for $ 55,000 for director’s fees.

this an amount of $ 22,875 was paid in cash and $ 32,125 was issued in shares of the Company’s common stock under the 2021 Equity

Incentive Plan.

On January 1, 2024 the Company issued 11,854 shares of common stock.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

11 - TAXES ON INCOME:

2 unchanged sentences

is taxed under U.S.

Accordingly, the applicable federal corporate tax rate in 2023 is 21 %.

the applicable state income tax rate in 2023 is 3.42%.

Accordingly, the applicable federal corporate tax rate in 2024 and 2023 is 21 %.

The applicable state

income tax rate in 2024 and 2023 is 3.42 %.

Ltd is taxed under Israeli tax laws.

Accordingly, the applicable corporate tax rate in 2023 is 23 %.

Accordingly, the applicable corporate tax rate in 2024 and 2023 is 23 %.

GmbH is taxed according to the tax laws in Germany.

Accordingly, the applicable tax rates are corporate tax rate of 15.825 % and trade

tax rate of 17.15 %.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

11 - TAXES ON INCOME:

tax rate of 17.15 % in 2024 and 2023

benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Law”):

23 unchanged sentences

2017 (the “2017 Act”) limits a taxpayer’s ability to utilize NOL carryforwards to 80% of taxable income.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited.

2 unchanged sentences

carryback and twenty-year carryforward period.

of December 31, 2023, InspireMD Ltd., an Israeli subsidiary, had a net carry forward tax loss of approximately $ 107 million.

Under Israeli

tax laws, the carry forward tax losses can be utilized indefinitely.

Israeli subsidiary is taxed in the New Israeli Shekel (“NIS”), which is different from its functional currency (U.S.

The change in the Israeli subsidiary NOL’s for tax purposes is partly resulted by such rate differences.

of December 31, 2024 and 2023, InspireMD Ltd., an Israeli subsidiary, had a net carry forward tax loss of approximately $ 126 and $ 107

Under Israeli tax laws, the carry forward tax losses can be utilized indefinitely.

Israeli subsidiary is taxed in New Israeli Shekel (“NIS”), which is different from its functional currency (U.S.

The change in the Israeli subsidiary NOL’s for tax purposes partly resulted by such rate differences.

before income taxes

1 unchanged sentence

SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES

Year ended December 31

ended December 31

($ in thousands)

1 unchanged sentence

InspireMD, Inc.

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

11 - TAXES ON INCOME (continued):

taxes on income

main reconciling item between the statutory tax rate of the Company and the effective tax rate is the change in valuation allowance in

respect of tax benefits from carried forward tax losses due to uncertainty of the realization of such tax benefits.

changes in the valuation allowance for the year ended December 31, 2023 and 2022 were as follows:

main reconciling item between the statutory tax rate of the Company and its subsidiaries and the effective tax rate is the change in

valuation allowance in respect of tax benefits from carried forward tax losses due to uncertainty of the realization of such tax benefits.

changes in the valuation allowance for the years ended December 31, 2024 and 2023 were as follows:

SCHEDULE OF CHANGES IN VALUATION ALLOWANCE

Year ended December 31

ended December 31

in thousands)

Balance at the beginning of the year

Balance at the beginning of the

Changes during the year:

Losses during the year (including foreign exchange rate effect)

Losses during the year

(including foreign exchange rate effect)

Balance at the end of the year

for Uncertain Tax position

following is a reconciliation of the total amounts of the Company’s uncertain tax positions during the year ended December 31,

2023 and 2022 were as follows:

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

for Uncertain Tax positions

following is a reconciliation of the total amounts of the Company’s uncertain tax positions during the years ended December 31,

2024 and 2023:

SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS

Year ended December 31,

ended December 31,

in thousands)

Balance at beginning of period

Increase in uncertain tax positions because of tax positions taken during the year

Balance at end of period

Balance at beginning of the year

Additions related to uncertain tax positions

taken this year

Balance at end of the year

summary of open tax years by major jurisdiction is presented below:

SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION

11 - TAXES ON INCOME (continued):

SCHEDULE OF DEFERRED INCOME TAX

in thousands)

Provision for vacation and recreation pay

Provision for vacation and recreation

Operating lease right of use assets

1 unchanged sentence

Share-based compensation

Marketable securities

Carry forward tax losses

Accrued severance pay, net

Accrued severance pay,

tax assets noncurrent

Less-valuation allowance

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

12 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION:

4 unchanged sentences

Raw materials and supplies

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

12 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (continued):

OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

11 unchanged sentences

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS

Year ended December 31,

($ in thousands)

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT

Year ended December 31,

ended December 31,

in thousands)

MGuard Prime™ EPS

principal customers:

* Other countries

don’t exceed 10% in the years ended December 2024 and 2023.

principal customers (part of revenues):

OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS

Year ended December 31,

tangible long lived assets are located in Israel.

ended December 31,

Sales percentage

The following table presents the Company’s long-lived assets by geographic region, which consist of property,

plant and equipment, net and operating lease right of use assets:

OF LONG-LIVED ASSETS BY GEOGRAPHIC REGION

in thousands)

United States

Total long-lived assets

TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)

14 – SEGMENT INFORMATION

Company has one operating

and reporting segment, that develops, manufactures and markets products for the treatment of carotid artery disease and other vascular

disease, including the Company’s proprietary CGuard™ stent platform.

The Company’s Chief Operating Decision Maker (“CODM”),

who is the CEO evaluates the Company’s performance based on its internal reporting which is consistent with the presentation in

the Company’s consolidated financial statements.

Accordingly, our CODM uses consolidated net loss to measure segment profit or

loss, allocate resources, and assess performance.

The CODM examines, within each operational function the employee salaries including the bonus and share based compensation, clinical trials

expenses within the research and development operations and certain other expenses.

following table summarizes the Company’s segment revenue, significant segment expenses, and segment loss.

OF SEGMENT REVENUE

ended December 31,

Cost of Revenues:

Material and Labor

cost of revenues

Cost of Revenues

Research and development (R&D)

Payroll and Benefits

Share based compensation

Clinical trials

Total Research and development

Selling and marketing (S&M)

Payroll and Benefits

Share based compensation

Total Selling and marketing

General and administrative (G&A)

Payroll and Benefits

Share based compensation

General and administrative

Financial Income, net;

Segment net Loss

15 - SUBSEQUENT EVENTS:

January 23, 2024, the Company granted 1,528,316 restricted shares of the Company’s common stock to employees and directors.

to December 31, 2024, the Company granted 2,253,445 restricted shares of the Company’s common stock to employees and directors.

The shares to employees are subject to a three-year vesting period, with one-third of such awards vesting each year.

1 unchanged sentence

are subject to a one-year vesting period.

January 23, 2024, the Company granted 563,499 restricted share units of the Company’s common stock to the chief executive

to December 31, 2024, the Company granted 558,417 restricted share units of the Company’s common stock to the chief executive officer.

The shares are subject to a three-year vesting period, with one-third of such awards vesting each year.

January 23, 2024, the Company granted to employees and directors options to purchase a total of 669,464 shares of the Company’s

to December 31, 2024, the Company granted to employees and directors options to purchase a total of 848,204 shares of the Company’s

common stock.

The options have an exercise prices of $3.14 per share, which was the fair market value of the Company’s common

stock on the date of the grant.

The options have an exercise price of $ 2.76 per share, which was the fair market value of the Company’s common stock

on the date of the grant.

The options to employees are subject to a three-year vesting period, with one-third of such awards vesting

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures